Phase II Study of Anlotinib in Patients With Advanced Non-small Cell Lung Cancer（ALTER0302）

Inclusion criteria

• pathology diagnosed with advanced NSCL with measurable lesions;
• Have failed for 2 lines of chemotherapy;
• 18-70years,ECOG PS:0-2,Life expectancy of more than 3 months;
• Other cytotoxic drugs,radiation therapy,or surgery≥4 weeks;
• main organs function is normal;
• must be agreed to take contraceptive measures during the study and within 6 months after end.

Exclusion criteria

• SCLC(including mixed with NSCLC);
• the central cavity of Squamous cell carcinoma and hemoptysis with NSCLC;
• patients failed to use the anti-tumor angiogenesis therapy;
• patients has many influence factors toward oral medications ;
• Brain metastases patients accompanied by symptoms or symptom control for less than two months;
• patients with severe and failed to controlled diseases,including: suboptimal blood pressure control;suffering from myocardial ischemia or above grade I myocardial infarction, arrhythmias and Class I heart failure;activity or failure to control severe infections;liver disease such as cirrhosis, decompensated liver disease, chronic active hepatitis;poorly controlled diabetes (FBG)>10mmol/L);urine protein≥++,etc.
• patients failed to heal wounds or fractures for Long-term;
• 4 weeks before enrollment, patients appeared NCI CTC AE grading >1 pulmonary hemorrhage; 4 weeks before enrollment, patients who appeared NCI CTC AE grade> 2 have other parts of the bleeding; patients has a tendency to bleed (eg active peptic ulcer) or are receiving thrombolytic or anticoagulant therapy such as warfarin, heparin or its analogues;
• patients occurred venous thromboembolic events within 6 months;
• patients has HIV-positive or organ transplantation;